Abstract

Background

Brentuximab vedotin is a CD30-directed antibody-drug conjugate. Retreatment with brentuximab
vedotin monotherapy was investigated in patients with CD30-positive Hodgkin lymphoma
(HL) or systemic anaplastic large cell lymphoma (ALCL) who relapsed after achieving
complete or partial remission (CR or PR) with initial brentuximab vedotin therapy
in a previous study (ClinicalTrials.gov NCT00947856).

Methods

Twenty-one patients with HL and 8 patients with systemic ALCL were retreated; 3 patients
with systemic ALCL were retreated twice. Patients generally received brentuximab vedotin
1.8 mg/kg intravenously approximately every 3 weeks over 30 minutes as an outpatient
infusion. The primary objectives of this study were to assess safety and to estimate
antitumor activity of brentuximab vedotin retreatment.

Results

The objective response rate was 60% (30% CR) in HL patients and 88% (63% CR) in systemic
ALCL patients. The estimated median duration of response for patients with an objective
response was 9.5 months (range, 0.0+ to 28.0+ months) at the time of study closure.
Of the 19 patients with objective response, 7 patients had not had an event of disease
progression or death at the time of study closure; duration of response for these
patients ranged from 3.5 to 28 months. Of the 11 patients with CR, 45% had response
durations of over 1 year.

Adverse events (AEs) occurring in ≥25% of patients during the retreatment period were
generally similar in type and frequency to those observed in the pivotal trials of
brentuximab vedotin monotherapy, with the exception of peripheral neuropathy, which
is known to have a cumulative effect. Grade 3 or higher events were observed in 48%
of patients; these were generally transient and managed by dose modifications or delays.
Deaths due to AEs occurred in 3 HL patients; none were considered to be related to
brentuximab vedotin retreatment.

Discussion

With the exception of a higher rate of peripheral motor neuropathy, retreatment with
brentuximab vedotin was associated with similar side effects seen in the pivotal trials.

Conclusions

Retreatment with brentuximab vedotin monotherapy is associated with response rates
in 68% (39% CR) of patients with relapsed HL and systemic ALCL.

Trial registration

United States registry and results database ClinicalTrials.gov
NCT00947856.